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Reiki/Energy Healing in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00065208
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : September 24, 2012
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Joan Fox, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE July 18, 2003
First Posted Date  ICMJE July 22, 2003
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE April 2005
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
  • To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. [ Time Frame: Each 30 minute session ]
  • To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels [ Time Frame: Each 30 minute session ]
  • To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma. [ Time Frame: throughout study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reiki/Energy Healing in Prostate Cancer
Official Title  ICMJE Effects of Energy Healing on Prostate Cancer
Brief Summary The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.
Detailed Description 120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Behavioral: Reiki
    Energy therapy - 8 biweekly sessions of 30 minutes
    Other Names:
    • Energy Therapy
    • Touch Therapy
    • Energy Healing
  • Behavioral: Pretend Reiki
    Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
    Other Name: Touch
  • Behavioral: Rest / Guided Imagery
    4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)
    Other Name: Guided Imagery
Study Arms  ICMJE
  • Experimental: Reiki
    Energy therapy
    Intervention: Behavioral: Reiki
  • Sham Comparator: Pretend Reiki
    Intervention: Behavioral: Pretend Reiki
  • Rest / Guided Imagery
    Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
    Intervention: Behavioral: Rest / Guided Imagery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2009)
79
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
120
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Newly diagnosed with prostate cancer
  • Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

Exclusion criteria:

  • Already involved in energy healing treatments
  • Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons
  • Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00065208
Other Study ID Numbers  ICMJE R21AT001120( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joan Fox, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Joan Fox, Ph.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP